Oct 25 2010
ViroPharma Incorporated (Nasdaq: VPHM) today announced that it has completed enrollment in its Phase 2 study evaluating subcutaneous delivery of Cinryze™ (C1esterase inhibitor [human]). This multi-center, open-label, multi-dose Phase 2 study is designed to evaluate the safety, pharmacokinetics and pharmacodynamics of subcutaneous versus intravenous administration of Cinryze in adolescent and adult subjects with hereditary angioedema (HAE). The company expects to have preliminary data from this study by the end of this year, which will help inform the next steps of development for this mode of administration.
"The rapid enrollment into this study is indicative of the interest in, and also the potential for, prophylaxis with a subcutaneous form of Cinryze," commented Judy Johnson, ViroPharma's vice president of clinical pharmacology and nonclinical development. "We look forward to completing this important study which will inform our path forward, including the Phase 3 study design. We are excited by the potential of a subcutaneous option for patients who choose prevention of their HAE attacks."
Cinryze was approved by the U.S. Food and Drug Administration in October 2008 for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE.